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Last Updated: June 25, 2021

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Details for New Drug Application (NDA): 040409


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NDA 040409 describes ANEXSIA 5/325, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the ANEXSIA 5/325 profile page.

The generic ingredient in ANEXSIA 5/325 is acetaminophen; hydrocodone bitartrate. There are sixty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; hydrocodone bitartrate profile page.
Summary for 040409
Tradename:ANEXSIA 5/325
Applicant:Specgx Llc
Ingredient:acetaminophen; hydrocodone bitartrate
Patents:0
Pharmacology for NDA: 040409
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 040409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANEXSIA 5/325 acetaminophen; hydrocodone bitartrate TABLET;ORAL 040409 ANDA SpecGx LLC 0406-0123 0406-0123-01 100 TABLET in 1 BOTTLE (0406-0123-01)
ANEXSIA 5/325 acetaminophen; hydrocodone bitartrate TABLET;ORAL 040409 ANDA SpecGx LLC 0406-0123 0406-0123-05 500 TABLET in 1 BOTTLE (0406-0123-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Oct 20, 2000TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Medtronic
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Boehringer Ingelheim

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